Written answers

Wednesday, 13 January 2016

Department of Health

Pharmacy Regulations

Photo of Tom FlemingTom Fleming (Kerry South, Independent)
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639. To ask the Minister for Health why the fee to register in pharmacy and the fee to remain registered, as a person and as a business, is a multiple of many European averages; when he will reduce the fee in line with same; and if he will make a statement on the matter. [1086/16]

Photo of Kathleen LynchKathleen Lynch (Cork North Central, Labour)
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The Pharmaceutical Society of Ireland (PSI) is an independent self-funded statutory body established under the Pharmacy Act 2007 (the Act). It is responsible for the regulation of pharmacy services in Ireland and regulates the professional practice of approximately 5,615 pharmacists, 1,880 pharmacies and 424 pharmaceutical assistants, in the interest of the health, safety and welfare of patients and the public.

The PSI’s statutory functions and duties are specified in the Act and include:

- registering pharmacists, pharmaceutical assistants and pharmacies, and maintaining the registers;

- improving the profession of pharmacy including ensuring that all pharmacists are undertaking appropriate continuing professional development (CPD);

- setting of standards for pharmacy education and training;

- accreditation of educational programmes for the pharmacy profession at different levels;

- quality assurance of standards, and the development of pharmacy practice;

- inspection and enforcement, including the taking of prosecutions; and

- handling complaints and disciplinary matters, including the imposition of sanctions.

The PSI is funded by registrant fees which are set out in Rules made by the PSI Council, following Ministerial consent. Following an extensive review of the PSI functions and related costs, and consultation with national stakeholders, the Pharmaceutical Society of Ireland (Fees) Rules 2008 were made setting out the quantum of fees. These were reduced by 10% in 2010 and most of them by a further 5% in 2014. The Council of the PSI has processes in place to review the level of fees on an annual basis and has committed to doing so in 2016.

It is important to note that the regulatory functions delivered by other regulators in Ireland and by pharmacy regulators in other jurisdictions differ considerably in scope and range from those provided by the PSI. For example, in Northern Ireland the investigative and enforcement activity is carried out by the Northern Ireland Department of Health, Social Services and Public Safety rather than the Pharmaceutical Society of Northern Ireland. In Great Britain, the General Pharmaceutical Council is responsible for regulatory functions including inspection and enforcement and the Royal Pharmaceutical Society of Great Britain is the professional body which provides professional guidance, networks and resources, with registration fees levied separately by both organisations. The PSI performs significant inspection and enforcement activities in respect of pharmacies which are not replicated by regulators in other jurisdictions. Therefore it is difficult to directly compare the regulatory registration fees applicable in differing jurisdictions and by other regulators in Ireland on a like-for-like basis.

There is a particular cost associated with the delivery of a regulatory system and associated services. Economies of scale apply when a larger proportion of registrants fund the model. The principle of the PSI application of fees is to recover costs based on who causes the cost or who benefits and is subject to the activities undertaken.

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